The development and production of therapeutic proteins and peptides is rapidly expanding in the pharmaceutical industry. Currently, there are many approved monoclonal antibody and protein therapeutics that have been approved or which are in clinical studies. This number will undoubtedly increase in the upcoming years. During the manufacturing process, transport, and storage, a protein therapeutic can be subjected to a variety of conditions that promote protein aggregation, denaturation, and adsorption that will result in loss of precious material. To protect against such degradation, protein therapeutics are usually formulated with excipients to provide the product with an acceptable shelf life for storage and shipping.
A related problem that can result from protein aggregation, denaturation, and adsorption is the “fouling” of surfaces that come into contact with blood, such as intravenous and intraarterial catheters. Adhesion of proteineaous material and the formation of biofilm on indwelling medical devices can contribute to catheter-related infections and are a major cause of patient morbidity and mortality, often resulting in premature catheter removal or replacement and an increase in costs and use of resources in this medical setting.
A need exists in the art for improved compositions and methods for preventing aggregation, denaturation, and adsorption of proteins. The present invention fulfills these and other needs.